Decalcification of the Aortic Valve by Vitamin K2 (Menaquinone-7)
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Surface area in (cm2/m2)
研究概览
简要总结
Aortic Stenosis is a common but fatal disease when it becomes symptomatic, specially if not treated. Until now surgery remains the only reliable and effective treatment.
In this study, the investigators will examine the effect of high dose of Menaquinone-7 (MK-7) supplementation (1000 mcg)/day on the progression of the aortic valve disease. The investigators hypothesize that MK-7 supplementation may slow or even reverse the progression of the disease process.
详细描述
The study is a randomized clinical trial that will use Cardiac Echography and multi-detector computed tomography to compare the changes in the Aortic Valve Calcification Score (AVCS) over 3 years when using:
- 1000 mcg/d Vitamin K2 (menaquinone-7) + 5000 IU/d Vitamin D3
- 5000 IU/d Vitamin D3 as a control group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AVCS > 300 without aortic valve stenosis requiring operation
- •Focus on patients with:
- •Bicuspid aortic valve
- •Dialysis or CKD
- •Statin treatment
排除标准
- •Use of Vitamin K antagonist
- •Malabsorption Problem
- •LVEF < 40%
- •A life expectancy < 3 years
研究组 & 干预措施
Interventional
1000 mcg/day of Vitamin K2 + 5000 IU/day Vitamin D3 as a treatment to decalcifiy the valve
干预措施: Vitamin K2 (Menaquinone 7) + Vitamin D3 (Dietary Supplement)
interventional
5000 IU/day of Vitamin D3 will be given to measure the progression of the disease along the time of the study
干预措施: Vitamin K2 (Menaquinone 7) + Vitamin D3 (Dietary Supplement)
结局指标
主要结局
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Surface area in (cm2/m2)
时间窗: 3 years
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in V max in (m/sec)
时间窗: 3 years
Evolution of the Aortic Valve Hemodynamic measured by echography: Change in Gradients in (mm Hg)
时间窗: 3 years
次要结局
- Activation of the MGP measured by the dp-uc MGP level which is a marker of vascular calcification.(3 years)
- Improvement of the quality of life of the patients(3 years)
- Improvement of dyspnea (at rest and effort)(3 years)
- Reduction of the Aortic Valve calcification measured by CT Scan(3 years)
研究者
Rodolph Frangi
Head of Department of Thoracic and Cardiovascular surgery
Hopital St. Georges, Ajaltoun